Zydus receives USFDA approval for anticonvulsant drug

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Zydus Cadila has received the final approval from the USFDA to market Carbamazepine Extended-Release Tablets USP (US RLD – Tegretol XR), 100 mg, 200 mg, and 400 mg. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.

Carbamazepine is an anticonvulsant agent. It works by reducing excessive nerve signals in the brain and restoring the normal balance of nerve activity. This medication is used to treat certain types of seizures (partial, generalized tonic-clonic, mixed) and certain types of nerve pain (trigeminal and glossopharyngeal neuralgia).

The group now has 248 approvals and has so far filed over 350 ANDAs since the commencement of the filing process in FY 2003-04